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First Approval Under New Priority Voucher Program

[ Price : $8.95]

FDA approves Augmentin XR (amoxicillinclavulanate potassium) through the new Commissioners National Priority Voucher pilot program...

FDA Qualifies 1st AI Drug Development Tool

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FDA qualifies its first artificial intelligence drug development tool, which will be used in metabolic dysfunction-associated stea...

FDA Issues Promotional Guide for Biosimilars/Reference Biologics

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FDA posts a final guidance entitled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Prod...

FDA Says Looking at Safety of RSV Infant Therapies

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FDA advises the companies manufacturing RSV therapies for infants that the agency is taking a new look at the therapies safety.

Envoy Medical QS Violations

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FDA warns Saint Paul, MN-based Envoy Medical about Quality System violations in its manufacturing of the Esteem II implantable hea...

FDA Broadens Covid Vaccine Probe to Include Adult Deaths

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FDA opens a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines after probing pediatric d...

Experts Call for Overhaul of FDA Revolving Door Rules

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Two pharmacist-attorneys (BakerHostetler) urge Congress to strengthen federal restrictions on how senior FDA officials move into p...

Prescription to Nonprescription Switch MAPP

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CDER issues a Manual of Policies and Procedures for when a reference-listed drug switches from prescription to nonprescription mar...

Petition Urges FDA to Overhaul Biosimilar Approval Rules

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A biosimilars scholar files a citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval require...

FDA OKs 1st Cellular Therapy for Severe Aplastic Anemia

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FDA approves Gamida Cells Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia.